NATALIZUMAB – INJECTION Tysabri side effects medical uses and drug interactions

natalizumab – injection, Tysabri

WARNING: Natalizumab increases the risk of a rare but serious brain infection (progressive multifocal leukoencephalopathy-PML). This risk may be higher if you use natalizumab for a long time or if you recently used or are currently using other medications that weaken the immune system/increase the risk of infection (such as immunosuppressants, cancer chemotherapy) or other medications that affect the immune system (immunomodulators). See also Side Effects and Drug Interactions sections. The risk of PML may also be higher if you have been infected with the virus that causes this infection (JC virus). Your doctor may order a test to see if you have been infected with this virus. Because this medication increases the risk of PML, it is usually used alone and only when other treatments have not worked or are not possible. In the US, natalizumab is only available to patients enrolled in the TOUCH Prescribing Program. In Canada, a similar program is called the Tysabri Care Program. There are two different TOUCH prescribing programs: MS TOUCH for patients with multiple sclerosis, and CD TOUCH for patients with Crohn’s disease. Only doctors, infusion centers, and pharmacies enrolled in these programs may prescribe, inject, or provide this medication to patients. Talk to your doctor about the risks and benefits of this medication and other treatment choices. If you and your doctor decide that this is the best treatment for you, your doctor can help you enroll in the TOUCH program. Your doctor will monitor you closely while you use this medication.

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USES: This medication is used to treat relapsing/remitting multiple sclerosis-MS. It helps prevent the immune system from attacking the nerves in the brain and spinal cord, decreasing the number of episodes of worsening and possibly preventing or delaying disability. Natalizumab is also used to treat moderate to severe Crohn’s disease (CD) that keeps returning. It helps prevent the immune system from causing inflammation/swelling in the bowels. Natalizumab is a monoclonal antibody.

HOW TO USE: Read the Medication Guide before starting natalizumab and each time you receive another dose. Ask your doctor, nurse, or pharmacist any questions you have about this medicine. This medication is given by a healthcare professional in an infusion center every 4 weeks or as directed by your doctor. It is injected slowly into a vein over 1 hour. It should not be given rapidly. You will be monitored for 1 hour after your treatment is finished to ensure there are no serious reactions to the medication. Use this medication regularly to get the most benefit from it. Do not miss any doses without your doctor’s approval. Tell your doctor if your condition worsens. If your condition does not improve after 12 weeks of treatment for Crohn’s disease, your doctor will need to change your treatment plan.

SIDE EFFECTS: Headache, joint pain, redness/irritation at the injection site, swelling hands/feet/ankles, or changes in menstrual cycle may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Tell your doctor immediately if you have any side effects while receiving this drug or shortly after treatment is finished. Examples of these side effects may include chills, fever, flushing, nausea, dizziness, tiredness, and chest pain. Tell your doctor immediately if any of these unlikely but serious side effects occur: severe/persistent headache, stiff/painful neck, fast/pounding heartbeat, signs of infection (such as fever, persistent sore throat, breathing problems, unusual vaginal discharge, painful/frequent urination), mood changes (such as depression, suicidal thoughts), severe stomach/abdominal pain. This drug increases the risk of a rare, possibly fatal, brain infection (see Warning section for more details). This condition may occur during or after treatment. Tell your doctor right away if you have any new or worsening symptoms that have lasted for several days, such as clumsiness, sudden change in your thinking, difficulty moving muscles, seizure, problems with speech, or vision changes. This drug may rarely cause serious liver problems. If you notice any of the following rare but very serious side effects, tell your doctor immediately: persistent nausea/vomiting, dark urine, yellowing eyes/skin, feeling tired/weak. A serious allergic reaction to this drug is rare. Seek immediate medical attention if you notice symptoms such as rash, itching/swelling, severe dizziness, or trouble breathing. This is not a complete list of possible side effects. Contact your doctor or pharmacist for other effects not listed above.

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QUESTION

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients that can cause allergic reactions. Talk to your pharmacist for more details. Do not use this medication if you have ever had progressive multifocal leukoencephalopathy-PML. Before using this medication, tell your doctor or pharmacist your medical history, especially if you have a weakened immune system, current infections, history of certain virus infections, or mental/mood disorders. During pregnancy, use this medication only when clearly needed. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

DRUG INTERACTIONS: Keep a list of all the products you use and share it with your doctor and pharmacist. This document does not contain all possible drug interactions. Some products that may interact with this drug include other drugs that weaken the immune system/increase the risk of infection, other drugs that affect the immune system, and long-term use of corticosteroids.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately.

NOTES: Laboratory and/or medical tests may be performed before and during treatment to monitor your progress or check for side effects. Talk to your doctor about lifestyle changes that may benefit you, such as stress reduction programs, maintaining a healthy diet, and approved exercise programs for MS patients.

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